Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 26, 2009
Last updated: January 18, 2013
Last verified: January 2013

Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.

Condition Intervention Phase
Active Rheumatoid Arthritis
Arthritis, Rheumatoid
Rheumatoid Arthritis
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sustained remission (using Disease Activity Score based on a 28-joint count) [ Time Frame: 91 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response (using Disease Activity Score based on a 28-joint count, modified total Sharp Score, Health Assessment Questionnaire) [ Time Frame: 52 weeks and 91 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 306
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
etanercept + methotrexate; etanercept + methotrexate
Drug: etanercept
Other Name: Enbrel


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of early rheumatoid arthritis.
  • Methotrexate (MTX) naive.
  • Active early rheumatoid arthritis at the time of enrollment.

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
  • Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
  • Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00913458

  Show 58 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00913458     History of Changes
Other Study ID Numbers: 0881X1-4524, B1801020
Study First Received: May 26, 2009
Last Updated: January 18, 2013
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics processed this record on July 10, 2014